Movement Sonification as an add-on to Immediate Post-event Psychotherapeutic Intervention in the Management of Acute Stress Disorder: a Feasibility and Acceptability Study

Обзор

Natural disasters, conflicts, persecution, population displacement, often traumatic migration experiences, and terrorist attacks are all factors that currently expose a significant proportion of the world's population to potentially traumatic events (PTEs). When a person is exposed to a PTE, symptoms of acute stress disorder (ASD) may occur in the immediate aftermath of the PTB, i.e., within the month following the event. These symptoms are dominated by dissociation, which includes depersonalization, i.e., the feeling of being disconnected from one's body. Managing these symptoms can prevent the subsequent onset of post-traumatic stress disorder (PTSD), a serious illness and public health concern. The recommended treatment combines an immediate post-event psychotherapeutic intervention (IPPI) and, where appropriate, medication with anxiolytics from the antihistamine class or antipsychotics

Подробное описание

In France, IPPI is carried out by the medical-psychological emergency units (CUMP) in each department. Patients are referred to these units by the CUMPs themselves when they are called out by the SAMU (emergency medical service) to the scene of mass accidents (attacks, fires, suicides in public places, etc.), or by departmental doctors and medico-legal emergency services for individual EPTs (sexual or physical assault, etc.). In Seine-Saint-Denis, the CUMP 93 receives 60 to 100 patients per year in the immediate post-traumatic phase.

The purpose of IPPI is to reconnect the traumatic experience with known representations. These interventions have demonstrated effectiveness,although their preventive impact on PTSD remains limited. Movement sonification is an augmented auditory reality technique that transforms a patient's movements into sound through connected wristbands and a speaker system. By enriching bodily perception, this technique may enhance the efficacy of trauma-focused psychotherapies.

This study aims to assess the acceptability and feasibility of using movement sonification in combination with IPPI for the treatment of ASD. It thereby addresses an urgent need for primary prevention of PTSD.

Вмешательства

• Устройство The sonification of movement is an act studied in this research.
  The sonification of movement is an act studied in this research at visit 1, visit 2 and visit 3

Первичные конечные точки

• Evaluate the feasibility of movement sonification in association with IPPI in the treatment of ESA. [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Dissociative symptoms [Срок оценки: 6 weeks]
• Dissociative symptoms [Срок оценки: 6 weeks]
• Agency (sense of control over the external environment) [Срок оценки: 6 weeks]
• The overall clinical response [Срок оценки: 6 weeks]
• The overall clinical response [Срок оценки: 6 weeks]
• Overall functioning [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]
• Symptoms associated with ESA in patients with initial symptoms of traumatic dissociation, compared to those without [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Patients aged 18 and over
• Who have experienced a potentially traumatic event (PTE) other than the death of a loved one
• Who have been referred to the medical-psychological emergency unit (CUMP 93) within one month of the PTE
• Who are experiencing acute stress disorder (ASD) according to DSM-5 criteria
• Have health insurance
• Have signed a written informed consent form

Критерии исключения

• Severe motor impairment rendering the use of sonification technology impractical
• Deaf, mute, or hearing-impaired patients
• Adults under guardianship or conservatorship, under judicial protection, or deprived of liberty
• Suffering from chronic psychotic disorder or bipolar disorder
• Central neurological disease defined by a medical report (including brain damage, cortical or subcortical atrophy, dementia, stroke, transient ischemic attack, head trauma, epilepsy, or seizure)
• Presenting a proven severe risk of suicide
• Substance use disorder (excluding tobacco)
• Pregnant or breastfeeding women
• Participation in another interventional study on ESA

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Hôpital Avicenne — Bobigny

Идентификаторы

NCT: NCT07307937 · APHP241593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗